| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07116694 | Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder | PHASE2 | COMPLETED | 33 | — | — | Jun 19, 2025 | Oct 7, 2025 | Apr 6, 2026 | 5 | United States |
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
| Arm | Type | Description |
|---|---|---|
| BXCL501 Sublingual film | EXPERIMENTAL | Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine |
| Name | Type | Description |
|---|---|---|
| BXCL501 Sublingual Film | DRUG | Single dose BXCL501 120 mcg |
Inclusion Criteria for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a prim...